Don’t use pillows to shape babies’ heads, FDA warns


Parents and caregivers should not use infant head molding pillows that are intended to change the shape of an infant’s head or claim to treat a medical condition, the U.S. Food and Drug Administration said Thursday. .

“The use of head-shaping pillows may create an unsafe sleeping environment for infants and may contribute to the risk of choking and death,” the FDA said in a statement. Press release.

The FDA statement clarifies that pillows, created with an “indent or hole in the center” to cradle a baby’s head while sleeping on their back, are not FDA approved.

“The FDA is not aware of any demonstrated benefit of using pillows to shape the heads of infants for medical purposes,” the agency said in a statement. “The use of head-shaping pillows can create an unsafe sleeping environment for infants and may contribute to the risk of choking and death.”

Infant head molding pillows are intended to treat or prevent flat head syndromeor plagiocephaly, a common problem in babies because they spend a lot of time sleeping on their backs, According to the UK National Health Service.

The FDA press release explains that flat head syndrome usually goes away on its own, is not painful for infants, and does not cause developmental problems.

“If you have a pillow to model a baby’s head, throw it away; don’t give it and don’t give it to anyone else,” the agency said.

For healthcare providers, the FDA recommends that they discourage the use of pillows to shape the heads of infants and ensure that patients understand the risk of infant death when using them. The FDA advises healthcare providers to promote awareness of safe sleep environments and educate patients about safe treatment options for flat head syndrome.

If parents notice an unusual head shape in infants, they should seek advice from their healthcare provider. Helmets, headbands, and caps are FDA-approved options that healthcare providers may offer to treat flat head syndrome.

According to the FDA, using pillows to shape an infant’s head could delay needed evaluation and treatment, not only for flat head syndrome, but also for more serious conditions, such as craniosynostosis, where the bones of a developing infant’s skull come together too soon.

According to Dr. Sarah Schaffer, a pediatrician at Children’s National Hospital, infant head shaping pillows are readily available and can be found at many major infant retailers.

“Hopefully this recommendation will lead to their removal from these websites,” Schaffer said.

“Sudden unexpected infant death syndrome (SUID), which includes sudden infant death syndrome (SIDS), is the leading cause of death from injury in infants,” the American Academy of Pediatrics said. their website. “Sleep is a big challenge for families with babies, but following safe sleep recommendations can prevent many SUID deaths.”

To create a safe sleeping environment, infants should sleep on their backs in a portable blanket on a firm, level sleeping surface according to the National Institutes of Health. There should be no toys, blankets or other objects in their sleeping area.

“Don’t use a pillow or head-shaping device that doesn’t come with your baby gear,” Schaffer said, noting that car seat tethers are also dangerous.

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